Regulatory Administrator

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I'm working with a medical device company in Galway for the opening of Regulatory Administrator. The company hold a portfolio of 13,000 products and are at the forefront of the medical device industry. Today, 99,000 employees are working to help people live not just longer, but better, in the more than 150 countries.The Authorised Representative (AR) Regulatory Administrator supports the administration and development of AR activities within the company Abbott according to appropriate procedures and processes. The AR Regulatory Administrator also supports the nominated Person Responsible for Regulatory Compliance (PRRC) to ensure that appropriate oversight of activities is maintained and any updates required are actioned through the RDIL Quality System. What will I be doing as Regulatory Administrator?Act as an initial and ongoing point of contact for customer sites and external regulators and others for AR related requests.Collation of electronic and paper documents to allow the registration or removal of products according to proceduresReview of external databases and update of external databases to ensure that information related to products and manufacturers is correctly assigned.Administer and deliver requests for documents such as Certificates of Free Sale from external Competent Authorities as requiredForward documents from the manufacture, AR or Competent Authority as required.Appropriate administration of documents related to all type of AR activities.Communicate any complaints or potential complaints to the PRRC, Customer site and complaint handling systems as required Follow the companies policies, procedures and methodologies.Process Purchase Order Requisition numbers and submit invoices to Accounts Payable as required.Complete any other duties as may be assigned by the PRRC or line managerRequirmentsExperience of AR activities previously is desirable but not essentialExperience in medical devices or IVD regulation or regulatory activities is desirable but not essential.Bachelor's Degree in a related field is required is desirable but not essential.In order to interact with sites on different time zones occasional out of hours working required.Excellent administrative, organisational and business support skills, with the ability to multi-task and to work calmly under pressure.Excellent communication skills (written & verbal across cultures).Ability to coordinate meetings (by phone, video conference and face to face) to drive results If you'd like to discuss the chance of becoming Regulatory Administrator , please send across your current CV and we can have a confidential conversation about this opportunity. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales